The Effect of Single Dose Paracetamol on the Lower Airways of Asthmatic and Healthy Children
Recruitment status was Recruiting
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Purpose
Asthma is a common inflammatory airway disease. Several researches have demonstrated a possible connection between asthma and exposure to paracetamol.
Our hypothesis is that even a single dose of paracetamol is sufficient to cause a measurable change in lung functions.
This trial aims to identify a possible effect of single dose paracetamol on lower airway function.
| Condition | Intervention |
|---|---|
|
Asthma |
Drug: paracetamol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science |
| Official Title: | The Effect of Paracetamol on Lower Airway Obstruction in Asthmatic Versus Non Asthmatic Children |
- A measurable change in lung functions in response to paracetamol exposure. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2010 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: asthmatic subjects
Asthmatic children will be randomly exposed to paracetamol and placebo consecutively and their lung functions will be blindly compared.
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Drug: paracetamol
single dose of paracetamol 15mg/kg.
Other Names:
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Healthy children
Children with no asthma as control group.
|
Drug: paracetamol
single dose of paracetamol 15mg/kg.
Other Names:
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Detailed Description:
Asthma is a common inflammatory airway disease and its prevalence is on the rise all around the world, Most significantly in children under 5 years.
Paracetamol is one of the most common drugs used with children at thus age groups and several studies have proved a causative connection between exposure to paracetamol and asthma prevalence as well as other allergic conditions.
The mechanism is presumably by reduction of glutathione level, resulting in oxidative burst and formation of reactive oxygen species (ROS).
In addition, paracetamol maybe directly cytotoxic to pneumocytes if given in overdose.
The goal of this research is to identify and quantify the effect of single dose of paracetamol on lung functions of asthmatic and healthy subjects.
The study group will include 40 children aged 7-16 years, who are known to have asthma and a control group of 20 healthy children.
The children will be randomized to receive a dose of paracetamol or placebo, and lung functions will be measured by both spirometry and Fraction of expired Nitric Oxide (FeNO) test.
Each child will receive both paracetamol and placebo, randomly in to consecutive tests, thus children will serve as their own control.
Eligibility| Ages Eligible for Study: | 7 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- age: 7-16 years
- research group: children who have been diagnosed as asthmatic according to the American thoracic society (ATS) criteria
- control group: children who are not known to have asthma
Exclusion Criteria:
- paracetamol sensitivity
- children with any kind of chronic disease (except asthma)
- children with non asthma related chronic lung disease
- acute asthma attack
- children on systemic steroids
Contacts and Locations| Contact: Ruth Soferman, M.D | 972-3-6975691 | ruthso@tasmc.health.gov.il |
| Contact: Assaf Tsivion, M.D | 972-52-7360333 | assaft@hotmail.com |
| Israel | |
| Tel Aviv Sourasky Medical Center | Recruiting |
| Tel Aviv, Israel | |
| Sub-Investigator: Assaf Tsivion, M.D | |
| Principal Investigator: | Ruth Soferman, M.D | TASMC |
More Information
No publications provided
| Responsible Party: | Dr. Ruth Soferman, Tel-Aviv Sourasky Medical Center, Israel, Tel-Aviv Sourasky Medical Center, Israel |
| ClinicalTrials.gov Identifier: | NCT01073748 History of Changes |
| Other Study ID Numbers: | TASMC-10-RS-422-CTIL |
| Study First Received: | February 22, 2010 |
| Last Updated: | January 23, 2011 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
Asthma Acetaminophen paracetamol |
FeNO Spirometry Lung function |
Additional relevant MeSH terms:
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Acetaminophen |
Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013